This invention relates to dispensing units for ketorolac topical gel formulations which are comprised of the gel formulation in a gas-impermeable multi-layered container.
Ketorolac and its pharmaceutically acceptable salts are known to be effective in treating inflammation and pain in mammals. See, e.g., U.S. Pat. No. 4,089,969 and U.S. Pat. No. 4,454,151. Dispensing units for ketorolac topical gel formulations require specific packaging specifications in order to maintain chemical stability of the formulation and physical integrity of the container. For example, the use of containers which are constructed of only polyolefins for dispensing units for ketorolac topical gel formulation results in undesirable changes in the formulation due to solvent evaporation. We have discovered that a dispensing unit for ketorolac topical gel formulations which is comprised of a container constructed of a polyolefin inner layer and a metal foil outer layer will maintain the chemical stability of the formulation contained within while at the same time the physical integrity of the container is maintained.